Mini Experiment Document
for
Experiment Title
Op Nom Name: Name
Date
National Aeronautics and Space Administration
Lyndon B. Johnson Space Center
Houston, Texas
DOCUMENT APPROVAL SHEET
International Partner (IP)
Signature Page
DATE
Date
Mini ED
for
Full Experiment Title
(Op Nom)
APPROVED:
Name
Principal Investigator
DATE
Name
Project Scientist
DATE
Name
BDC Representative
DATE
APPROVED:
APPROVED:
DOCUMENT APPROVAL SHEET
NASA Signature Page
DATE
Date
Mini ED
for
Full Experiment Title
(Op Nom)
APPROVED:
Name
Lead Increment Science Coordinator
DATE
Name
NASA ISSMP Representative
DATE
APPROVED:
NATIONAL AERONAUTICS AND SPACE ADMINISTRATION
Lyndon B. Johnson Space Center
Houston, Texas
DOCUMENT CHANGE/
REVISION LOG
CHANGE/
REVISION
Rev.0
DATE
Date
PAGE
DESCRIPTION OF CHANGE
Initial Release
ALTERED PAGES MUST BE TYPED AND DISTRIBUTED FOR INSERTION.
1
OF
1
PAGES
AFFECTED
All
MINI ED FOR OP NOM NAME
PURPOSE
This document was developed to collect and properly document the baseline data
collection (BDC) and data sharing requirements for experiments not managed by the
Johnson Space Center International Space Station Medical Project (JSC/ISSMP), but
that utilize United States Operating Segment (USOS) crewmember subjects. The
document will aid the JSC ISSMP Increment Science Coordinator (ISC) in
understanding the experiment’s requirements and the information will flow into the
BDC Plan, Informed Consent Briefing (ICB) overview, and Data Sharing Plan (DSP).
Instructions on how to fill out each field in the following tables are provided in
Appendix A to assist the Principal Investigator (PI) in filling out the tables for his/her
experiment.
It is important that the requirements documented in these tables match the research
protocol approved by the applicable institutional review boards (IRB). Once the ICB
has been conducted, protocol changes will require a delta-ICB and crew consent form
re-signature.
Note:
PIs should assume that BDC rooms will be completely empty for each BDC
session. The size of the room and all hardware needed (e.g., sinks,
refrigerators, gloves, etc.) should be documented in the Hardware or Facility
Requirements section of the Preflight/Postflight BDC tables. ISSMP will
indicate its ability to furnish hardware or facility requirements that are
requested from ISSMP resources. A response of “wilco” indicates that
ISSMP can and will provide the requested resource. A “nowilco” indicates
ISSMP cannot or will not accommodate the request, which will become the
responsibility of the experiment’s sponsor.
CONFIGURATION MANAGEMENT OF MINI ED
After initial signature, changes to this document will be controlled by the Lead
Increment Science Coordinator in coordination with the International Partner (IP) BDC
Coordinator and/or Payload Integration Manager/Research Program Office (PIM/RPO)
representative (hereinafter referred to as BDC Representative) and PI. Changes
affecting OZ resource requirements must first be approved in programmatic documents
via Change Evaluation Form (CEF) before being changed in the Mini ED and
implemented. BDC and data sharing will be implemented/managed through the
increment specific plans.
ROLES, RESPONSIBILITIES, AND EXPECTATIONS
Applicable to human life sciences research projects requiring BDC (e.g.,
ESA/JAXA/CSA and some NASA sponsored payloads) that are not managed by
JSC/ISSMP. All projects managed directly by ISSMP will complete nominal
documentation as required.
RPWG Inputs for inclusion on Increment
complement (manifest inputs, crew time inputs,
BDC time inputs, etc.)
IDRD Annex 5 Review
Mini-ED inputs
CPHS submittal and renewal
BDC
Rep.
PI
X
X
X
X
X
X
X
X
X
X
X
X
ISC
X1
BDC Representative should
provide status to ISC
regarding approval status
BDC Representative should
provide status to ISC
regarding approval status
BDC Representative should
provide status to ISC
regarding approval status
HRMRB submittal and renewal
Applicable IP IRB submittal and renewal
ICB scheduling
ICB briefing presentation development for
individual project
ICB notebook development – to include
presentation for each experiment as well as
BDC schedule
TRR Package development
Scheduling of TRR
Conduct of TRR and Action closure
BDC Schedule review/input
BDC Plan development
BDC Plan inputs/review
Data Sharing Plan development
Data Sharing Plan input/review
IP BDC Session Scheduling (JSC and GCTC)
IP BDC Session Scheduling at IP Location
X
X
X
X
X
X
X
X
X
X
X
X
X
X
ISC will provide example
documentation if requested.
X
X
X
X
BDC Representative should
inform ISC of session date,
time, and as-run duration
X
BDC Session coordination
Inputs for as-run BDC times
Tracking of as-run BDC times
Data distribution to PI – only applicable to data
requested via data sharing from NASA Space
Medicine division or other investigations
Badging @ JSC/KSC/Dryden
1
Only responsible for review of BDC Session times.
Comments
X
X
X
X
X
X
X
X
Communication: In order to maintain consistency across increments, allow for
accurate documentation of PI requirements, and to ensure that the BDC Representative
is aware of all activities, the following flow will be standard practice for all
increments. Any and all inputs/documents that are required by the ISC will nominally
flow from the PI to the BDC Representative to the ISC. The BDC Representative is
expected to function as a liaison between the PI and ISC. However, if direct
communication between the ISC and PI is necessary or does occur, such
communication should always include the BDC Representative to ensure that all
parties have the same information. If issues with potential science impacts are
discussed, it will be the responsibility of the BDC Representative to inform and
include the IP Project Scientist in the discussions.
Responsibilities of the BDC Representative /PI: It is the responsibility of the BDC
Representative and PI to ensure that all required documentation and inputs necessary
for inclusion on an increment research complement are completed as required to
support BDC/ICB/Data Sharing milestones or deliverables.
For example, in order for a crew to be briefed on a research protocol, Committee for
the Protection of Human Subjects (CPHS), Human Research Multilateral Review
Board (HRMRB), and applicable IP IRB approvals must be obtained and those
approvals must be up to date at the time of the crew briefing. If approvals are not
current, the experiment will not be included in the briefing, and either a delay in the
briefing or a delta briefing will need to be requested.
Responsibilities of the ISC: It is the responsibility of the ISC to schedule and
coordinate all activities that relate to BDC and Data Sharing. Outside of BDC
(includes performance of ICB) and data sharing, all other activities, inputs, and
requirements levied upon the project for inclusion on a particular increment are the
responsibility of the PI and the BDC Representative. To aid the BDC Representative
and PI in meeting deadlines for the planned schedule of activities, the ISC will provide
them with a schedule of targeted dates for activities such as CPHS, HRMRB, ICB,
BDC, data sharing, etc. However, it should be noted that if any milestones or
deadlines for activities in relation to BDC, ICB, and data sharing are missed by the
BDC Representative /PI, the ISC will only reschedule activities or delay the release of
documents if it can be easily accommodated. For example, if the BDC Representative
/PI does not submit the documents required for performance of an ICB by the due
date, the ISC will only schedule a delta briefing if the crew schedule can accommodate
it, and if it does not require a significant amount of rework/coordination by the ISC.
LIST OF TABLES
Table
Page
1
EXPERIMENT OVERVIEW ....................................................................................... 1
2
EXPERIMENT SUMMARY........................................................................................ 2
3
3.1-1
3.2-1
OPERATIONAL OVERVIEW .................................................................................... 3
PREFLIGHT SESSION ................................................................................................ 4
POSTFLIGHT SESSION ............................................................................................. 5
3.3
3.4
SAMPLES..................................................................................................................... 6
MEASUREMENTS ...................................................................................................... 6
4
BASELINE DATA COLLECTION HARDWARE AND SOFTWARE ..................... 7
5
TRAINING SUMMARY.............................................................................................. 8
ACRONYMS AND ABBREVIATIONS
0g
1-g
Zero Gravity
1 Gravity
ASI
Agenzia Spaziale Italiana (Italian Space Angency)
BDC
BDCF
Baseline Data Collection
Baseline Data Collection Facility
CEF
Co-I
CPHS
CSA
Change Evaluation Form
Co-Investigator
Committee for the Protection of Human Subjects
Canadian Space Agency
DFRC
DSP
Dryden Flight Research Center
Data Sharing Plan
ECG
ED
ESA
FD1
Electrocardiogram
Experiment Document
European Space Agency
Flight Day 1
GCTC
GSP
Gagarin Cosmonaut Training Center
Ground Support Personnel
HRMRB
Human Research Multilateral Review Board
ICB
ID
IDRD
IP
IRB
ISC
Informed Consent Briefing
Identification
Integrated Data Requirements Document
International Partner
Institutional Review Board
Increment Science Coordinator
JAXA
JSC
Japan Aerospace Exploration Agency
Johnson Space Center
KSC
Kennedy Space Center
L-
Launch minus
Min
Minutes
N/A
Not Applicable
Nowilco
Ops
USOS
ISSMP cannot accommodate request
Operations
United States Operating Segment
PI
PIM
Principal Investigator
Payload Integration Manager
R+
RPWG
Return Plus
Research and Planning Working Group
U.S.
United States
Wilco
ISSMP will provide requested resource
TABLE 1 EXPERIMENT OVERVIEW
Investigation Title
Ops Name
Subjects Required
Name
Address
E-mail
Principal Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Name and Address of Organization Conducting the Research
Sponsoring Agency
Destination of table information: BDC plan, DSP, IRB package and ICB presentations
1111
Fax
Telephone
TABLE 2 EXPERIMENT SUMMARY
Experiment Type
Preflight, In-flight, & Postflight
Pre/Post Only
In-flight Only
Experiment Description
Objectives
Relevance to Space and/or Earth-based Research
Baseline Data Collection Summary
In-flight Operations Summary
Destination of table information: One page summary used in DSP.
2222
TABLE 3 OPERATIONAL OVERVIEW
Preflight
Total Crew Time
(minutes)
Session Time
(1 g minutes)
Crew Time
In-flight
(0 g minutes)
Total Crew Time
(minutes)
Destination of table information: IRB package and ICB overview presentation
3333
Postflight
Total Crew Time
(minutes)
Session Time
(1 g minutes)
TABLE 3.1-1 PREFLIGHT EXPERIMENT SESSION OVERVIEW
Session
Title
Medical
Monitoring
Session
Time (min)
Schedule
Session ID
JSC
KSC
Location
GCTC
DFRC
Session Scenario
No.
Projected Time (min)
Session Flow
1.
2.
3.
4.
5.
6.
7.
Scheduling Constraints
Session Constraints
Session Unique Information
Yes
Yes
Hardware
Samples
No
No
Software
Measurements
Facility Requirements
Hazardous Waste
Gas Mixtures
If a Launch Slip of
ISSMP Disposition
Yes
Yes
No
No
Timeframe for Facility Access
days occurs, the LWilco
Comments:
No Wilco
Session(s) will need to be repeated
Destination of table information: BDC Plan
4444
TABLE 3.2-1 POSTFLIGHT EXPERIMENT SESSION OVERVIEW
Session
Title
Medical
Monitoring
Session
Time (min)
Schedule
Session
ID
Location
JSC
KSC
GCTC
DFRC
Session Scenario
No.
Projected Time (min)
Session Flow
1.
2.
3.
4.
5.
6.
Scheduling Constraints
1.
Session Constraints
1.
Session Unique Information
1.
Yes
Yes
Hardware
Samples
Facility Requirements
Hazardous Waste
Gas Mixtures
For a mission
greater than
ISSMP Disposition
No
No
Software
Measurements
Yes
Yes
No
No
Timeframe for Facility Access
days in duration, this session should be performed.
Wilco
No Wilco
Comments:
Destination of table information: BDC Plan
4444
TABLE 3.3 SAMPLES
Samples Acquired
Session ID(s)
Units
Volume/
Accuracy
Comments
Destination of table information: IRB package and DSP
TABLE 3.4 MEASUREMENTS
Measurement Name
Session ID(s)
Units
Range
Accuracy
Destination of table information: DSP
4444
Sample Rate
Acquisition
Method
Comments
TABLE 4 BASELINE DATA COLLECTION HARDWARE AND SOFTWARE
Location and Dates for BDC Activities
Hardware/Software
Item
Session
ID(s)
Total
Qty.
Provided
By
JSC
Scheduled
Days
KSC
Qty.
Scheduled
Days
7
Dryden
Qty.
Scheduled
Days
Russia
Qty.
Scheduled
Days
Qty.
Other
(Specify)
Scheduled
Qty.
Days
ISSMP
Wilco/
Nowilco/
N/A
TABLE 5 TRAINING SUMMARY
Session Title
Timeframe
Session Duration
Destination of table information: IRB package and ICB overview presentation
8888
Required No. of Sessions
Location of Training